A Study of MK-8189 in Participants With Bipolar I Disorder (MK-8189-020)

Merck Sharp & Dohme (MSD)

Status and phase: Active, not recruiting; Phase 1

Conditions: Bipolar I Disorder

Treatments: Drug: Placebo; Drug: MK-8189

Study type: Interventional

Funder types: Industry

Identifiers

NCT06273774

8189-020

MK-8189-020 (Other Identifier)

Details and patient eligibility

About

The goal of this study is to evaluate the safety and tolerability of MK-8189 in participants with stable bipolar I disorder. There will be no hypothesis testing in this study.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

The main inclusion criteria include but are not limited to the following:

• Meets diagnostic criteria for bipolar I disorder, manic or mixed features according to the Diagnostic and statistical manual of Mental Disorders TR (DSM-5 TR) and considered to be in a non-acute phase of their illness.
• History of receiving and tolerating antipsychotic medication within the usual dose range employed for bipolar I disorder.
• Body mass index is 18 and 40 kg/m^2, inclusive.
• If currently taking an antipsychotic, is able to discontinue it's use at least 5 days prior to study start and the duration of the study.

Exclusion criteria

The main exclusion criteria include but are not limited to the following:

• Untreated or uncompensated endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological abnormalities or diseases.
• Evidence or history of a primary DSM-5 axis I psychiatric diagnosis other than those specified for inclusion.
• History of cancer (malignancy).
• Evidence or history of mental retardation, borderline personality disorder, or organic brain syndrome.
• History of neuroleptic malignant syndrome or moderate to severe tardive dyskinesia.
• Substance-induced psychotic disorder or behavioral disturbance.
• DSM-5 TR defined substance use disorder within 3 months of screening.
• History of seizure disorder beyond childhood or is receiving treatment with any anticonvulsant to prevent seizures.
• Positive test(s) for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus.
• Major surgery or donation/loss of 1 unit of blood within 4 weeks prior to screening.
• Received any vaccine starting from 30 days prior to study intervention or is scheduled to receive any vaccine through 30 days following study intervention.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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32 participants in 4 patient groups, including a placebo group

Panel A: MK-8189 Dosing Regimen 1

Experimental group

Description:

Participants will receive MK-8189 once daily (QD) at dosing regimen 1 for up to 14 days.

Treatment:

Drug: MK-8189

Panel B: MK-8189 Dosing Regimen 2

Experimental group

Description:

Participants will receive MK-8189 QD at dosing regimen 2 for up to 14 days.

Treatment:

Drug: MK-8189

Panel C: MK-8189 Dosing Regimen 3

Experimental group

Description:

Participants will receive MK-8189 QD at dosing regimen 3 for up to 14 days.

Treatment:

Drug: MK-8189

Placebo

Placebo Comparator group

Description:

Participants will receive MK-8189-matching placebo QD for up to 14 days.

Treatment:

Drug: Placebo